Insulin is a polypeptide hormone secreted by β-cells of the pancreas.
Insulin is used for the treatment of diabetes and diseases connected therewith or resulting from it. Insulin is essential in maintaining normal metabolic regulation. Since the introduction of insulin therepy 90 years ago, the lives of millions of patients with diabetes have been saved, prolonged and improved. In the last decades, it has turned out that it is extremely important for a diabetic patient to maintain close control of the blood glucose level.
In Prog. Biophys. Mole. Biol. 91 (2006), 199 et seq., there is an overview of different forms of insulins.
Usually, insulin is administered by injections (subcutaneously). In Nat. Reviews Drug Disc. 1 (2002), 529 et seq., there is an overview of alternative routes for the administration of insulin.
In WO 2009/115469, acylated insulin analogues wherein one hydrophobic amino acid has been substituted with hydrophilic amino acids are mentioned. In WO 2009/115469, there is no mentioning of specific injectable pharmaceutical insulin formulations.
In WO 2008/015099, PEGylated, extended insulins are mentioned. In WO 2008/015099, there is no mentioning of specific pharmaceutical insulin formulations.
Briefly, WO 02/067969 relates to insulin formulations which are stabilised because they contain two different insulin species and, apparently, the description is focused on insulin lispro being one of the two insulin species.
For decades, insulin formulations with different properties have been developed and put on the market and those formulations have been prepared using a very large variety of additives. It is presumed that in the neutral insulin formulations put on the market, none contain insulin all of which is in the monomeric form.
Many patients take 2-4 insulin injections per day, e.g., for basal treatment and prandial treatment.
In 2007, there were 246 million diabetics in the world. In 2025, the number is expected to be about 380 million.